Boston Scientific initiates trial to evaluate industry’s first Modular CRM System 

On December 02, 2021, Boston Scientific Corporation started the MODULAR ATP clinical trial to examine the safety, performance, and effectiveness of the mCRM™ Modular Therapy System. The system comprises of two cardiac rhythm management (CRM) devices planned to collaborate to coordinate therapy: the EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD) System and the EMPOWER™ Modular Pacing System (MPS), which is intended to be the first leadless pacemaker capable of providing both bradycardias pacing support and anti-tachycardia pacing (ATP).

Kenneth Stein, M.D., FACC, FHRS senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific, said that since the EMPOWER MPS device can be delivered percutaneously through a minimally invasive approach without the use of leads, the mCRM System could preserve many of the advantages of the S-ICD System while giving an option for patients who subsequently develop a pacing need. The components of the system are designed to work cooperatively with each other, irrespective of when implanted, giving physicians the ability to offer personalised patient care while keeping options accessible in the future. 

The prospective, non-randomized MODULAR ATP clinical trial will enrol at up to 50 centres in the US, Canada, and Europe up to 300 patients.  These patients are guideline-indicated for an ICD or who already have an EMBLEM or EMBLEM MRI S-ICD System implanted. The trial will evaluate the system- and procedure-related complication-free rate of the EMPOWER MPS, the communication success between the EMPOWER MPS and the S-ICD System, and adequate pacing capture thresholds of the EMPOWER MPS.

According to DelveInsight’s Defibrillators Market & Competitive Landscape, the global Defibrillators Market was worth at USD 9.89 billion in 2020, increasing at a CAGR of 3.10% during the forecast period from 2021 to 2026, reaching USD 11.31 billion by 2026. The demand for Defibrillators is due to the growing cardiac disorders incidence, the integration of advanced technology, increasing investments by government and private manufacturers, and increasing awareness programs regarding cardiovascular disorders and usage of defibrillators, among others.

Moreover, DelveInsight’s Pacemakers Market & Competitive Landscape, the global Pacemakers Market was valued at USD 4.63 billion in 2020, growing at a CAGR of 5.81% during the forecast period from 2021 to 2026, to reach USD 5.78 billion by 2026. The demand for Pacemakers is primarily motivated owing to the increase in cardiovascular diseases (CVDs), superior treatment outcomes of sudden cardiac arrests, and increasing technological advancements.

BD acquires Venclose, Inc. to extend treatment innovations in Chronic Venous Disease 

On December 02, 2021, BD (Becton, Dickinson, and Company), a leading global medical technology company, acquired Venclose, Inc., a supplier of solutions for the treatment of chronic venous insufficiency (CVI), a disease resulting in malfunctioning valves and can lead to varicose veins.

According to DelveInsight’s Chronic Venous Insufficiency Market, it represents the growing therapeutic need within the healthcare system. Various studies report that up to 40% of women and 17% of men in the United States are impacted. The analysts estimate that Venclose is a leader in Chronic Venous Insufficiency treatment through its innovative Radio Frequency (RF) ablation technology platform intended for versatility, efficiency, and simplicity.

Paddy O’Brien, worldwide president of Peripheral Intervention for BD, said they are carrying out a new standard of excellence for people living with venous disease. That commences with providing physicians with innovative technologies. Their acquisition of Venclose will allow them to proffer a more robust portfolio of solutions to physicians treating the full range of venous conditions. The Venclose™ RF Ablation System strategically complements its category-leading portfolio of venous disease technologies. It aligns with their focus on innovations proffering transformative solutions to enhance outcomes for chronic disease and let the transition into new care settings.

Roche has rapidly developed additional testing options to differentiate mutations in the Omicron SARS-CoV-2 variant 

On December 03, 2021, Roche and TIB Molbiol, a recently taken over subsidiary within the Roche Diagnostics division, have added three more Research Use Only (RUO) test kits for the recognition of mutations present in the novel B.1.1.529 Omicron SARS-CoV-2 variant: VirSNip SARS Spike ins214EPE (RUO), VirSNiP SARS-CoV-2 Spike S371L S373P (RUO), VirSNip SARS Spike E484A (RUO). The World Health Organization (WHO) has classified the newly emerged SARS-CoV-2 variant, Omicron (B.1.1.529), as a COVID-19 variant of concern (VOC).

Thomas Schinecker, CEO of Roche Diagnostics, said that the COVID-19 pandemic is still an evolving and intricate situation, and Roche is carrying out in responding to healthcare’s biggest problems. The teams at TIB Molbiol have continuously worked since the new variant came, and now they can provide a test that can specifically detect the novel B.1.1.529 Omicron SARS-CoV-2 variant to comprehend its spread and behaviour better. There is still much to know about Omicron. It is vital to detect Omicron quickly and accurately, helping to inform ongoing research compromising the further development of therapeutics and vaccines and potentially halt or decrease the progression of this new variant.

The VirSNiP variant kits differentiate between unique mutations within the Omicron variant compared to other SARS-CoV-2 variants and are used on LightCycler® and cobas® z 480 analysers. Utilising a technology called qPCR (quantitative polymerase chain reaction), they can aid researchers with better variant detection and viral research and are among the first to address the number of unique mutations of the Omicron variant.

Linus Biotechnology Inc. receives FDA Breakthrough Device Designation for StrandDx™-ASD Exposome sequencing diagnostic 

On December 07, 2021, the US Food and Drug Administration Center for Devices and Radiological Health has granted Linus Biotechnology Inc.’s, a leader in precision exposome sequencing, StrandDx™-ASD diagnostic aid the designation as a Breakthrough Device for Autism Spectrum Disorder (ASD).

According to DelveInsight’s “Autism Spectrum Disorder Market”, about one in 160 children are affected. The World Health Organization (WHO) estimates the international Autism Spectrum Disorder prevalence is at 0.76%; however, this only accounts for approximately 16% of the global child population.

Dr Neil Kurtz, MD, physician, psychiatrist, and neurologist, and an advisor and director of the Company, said that they have the prospect for the first time in the history of medicine that evaluating a single strand of hair, physicians, patients, families, and scientists can get the physiological equivalent of a blood test for autism.

Manish Arora, PhD, BDS, MPH, Edith J. Baerwald Professor and Vice-Chair of the Department of Environmental Medicine and Public Health at the Icahn School of Medicine at Mount Sinai and co-founder and Chief Scientific Officer of the Company, added that their first precision exposome diagnostic, StrandDx™-ASD is being developed to guide patient care for the disease, which now affects 1 in 44 children in the U.S. Molecular biomarkers, like StrandDx™-ASD, are a significant step forward in precision medicine for autism and show the potential to deploy individualised early intervention. This designation is an essential milestone for Linus Biotechnology Inc. They look forward to working closely with the FDA to prioritise the development of StrandDx™-ASD and move it toward commercialisation.

StrandDx™-ASD is based on novel molecular biomarkers developed using Linus Biotechnology’s proprietary exposome and biological response sequencing platform, utilising a single strand of hair. According to the Breakthrough Device designation label, the intended use of StrandDx™-ASD will extend to patients from birth to 21 years, where the test will assess the likelihood of ASD in children from birth to 18 months old and aid in the Autism Spectrum Disorder diagnosis in patients aged 18 months to 21 years.

Restore Medical announces first in Human Trial for treatment of Heart Failure patients 

On December 07, 2021, Restore Medical Ltd., a clinical-stage MedTech company developing cardiac implants to treat congestive heart failure (CHF), announced promising preliminary results of the First-in-Human clinical trial of ContraBand™, a breakthrough treatment for congestive heart failure patients. The minimally-invasive, catheter-delivered implants are utilised for treatment of chronic left ventricular failure patients, where the heart cannot pump sufficient oxygen-rich blood through the body.  

Gilad Marom, CEO of Restore Medical, said that these first procedures are milestones in proving the ContraBand™ technology to be safe and effective for heart failure patients. This treatment’s positive impact on the millions of people suffering from this indication cannot be underestimated. Not only will it transform the quality of life of treated patients, but it will also decrease the tremendous financial burden resulting from patients being undertreated.

Congestive Heart Failure is a progressive, debilitating disease. It is one of the leading causes of mortality, with less than half of patients surviving five years after diagnosis and only 30% surviving ten years. With 25% of patients returning to the hospital within a month of discharge, it is also the leading cause of repeat hospitalisations. The disease affects tens of millions of people worldwide, including 6.2 million in the United States alone. It is considered the most significant unmet clinical and financial need facing global healthcare systems.

According to DelveInsight’s “Congestive Heart Failure Treatment Devices Market & Competitive Landscape”, the market leaders in the segment Abiomed, Inc., Medtronic, Abbott, Berlin Heart GmbH, Boston Scientific Corporation, HeartWare International, Inc., and LivaNova PLC, among others.

HelioLiver launches liquid biopsy test for early liver cancer detection

On December 06, 2021, Helio Health and its commercial partner, Fulgent Genetics, Inc., announced the commercial launch of HelioLiver™. This multi-analyte blood test incorporates cell-free DNA (cfDNA) methylation patterns and serum protein markers to detect hepatocellular carcinoma (HCC), the most common form of liver cancer. HelioLiver can detect HCC at its earliest stages when lesions are still tiny, an area where traditional standard-of-care imaging tools often fall short, with the potential to enable more curative treatment options known to increase five-year survival rates by up to 13 times compared to when cancer has metastasised.

Justin Chen Li, U.S. Chief Executive Officer, Helio Health, said that they are thrilled to offer patients at high risk of developing liver cancer a convenient and sensitive serial testing option to catch cancer early when it counts the most. They are proud to collaborate with Fulgent to launch this innovative, simple, and reliable test, which has the potential to redefine the future of cancer testing and foster better patient outcomes.

Brandon Perthuis, Chief Commercial Officer, Fulgent Genetics, added that with this partnership with Helio, their joint priority is to offer HelioLiver to providers and patients in a seamless manner. Leveraging their extensive commercial infrastructure, they are well-positioned to provide an easy ordering experience for providers with their representatives ready to offer the best-in-class white-glove service throughout the entire experience.According to DelveInsight’s Liquid Biopsy in Cancer Diagnostics Market & Competitive Landscape, the availability of a wide range of reagents and kits, easy accessibility to a broad range of assays, and the increasing prevalence of cancer are the major factors driving the growth of the liquid biopsy assay kits market.